FDA WARNING_LETTER - Pleasant Valley Farms of Berkshire, LLC - July 15, 2015

On August 21, 2015, the FDA issued a Warning Letter to Pleasant Valley Farms of Berkshire, LLC, following an investigation on June 15, 23, and July 15, 2015. The investigation found that the farm offered an adulterated animal for slaughter. Specifically, a dairy cow sold on October 20, 2014, and slaughtered on October 21, 2014, contained 0.2 ppm of ampicillin in kidney tissue, exceeding the FDA tolerance of 0.01 ppm (21 C.F.R. 556.40). This violates section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), deeming the food adulterated due to an unsafe new animal drug.

Additionally, the farm was cited under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), for holding animals under insanitary conditions where medicated animals with harmful drug residues could enter the food supply. Deficiencies included failure to maintain complete treatment records and systematically review records before slaughter.

The FDA deemed the firm's July 22, 2015, response inadequate